On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations. This is the first of several Calls to Action anticipated in CASAA's Action Plan. (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)
FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate.
I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.
The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.
I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.
I appreciate your consideration of my request and am happy to discuss this issue with you further.
- Create a document with your comment. You can use the above sample letter as a template and edit to make it your own.
- Access the comment form for the deeming regulation (FDA-2014-N-0189-0001): FDA Comment Form
- Click in the Comment field and copy and paste your comment from Step 1 into the box.
- Click in the First Name field and type your first name.
- Click in the Last Name field and type your last name.
- If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
- Click to uncheck the box, "I am submitting on behalf of a third party."
- Click the arrow next to the "Category" field to display a menu.
- Select a category
from the menu. We recommend "Individual Consumer" for individuals wishing to request an extension personally and not on behalf of any business or group.
NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns. There has been some criticism of this position, and FDA has indicated that it will be publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name. Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
- Click the Continue button. After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it. (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)
- On the Your Preview page, click to check the box "I read and understand the statement above."
- Click the Submit Comment button.
- After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below. (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below. Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment and comment number.)
- Please send the comment number to firstname.lastname@example.org. It is important that CASAA have a count of how many such requests have been made. (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)